The present invention relates to packaged medical appliances, and, in particular, to medical appliances which may be manually configured into a desired shape while sealed within a sterile, flexible envelope, without rupture of the seal and without loss of sterility.
The conventional method catheter consists of a long, flexible tube of pliable material, such as rubber or other suitable polymer, having a smooth, rounded open distal end, and an open proximal end. The catheter is intubated into a body orifice of the patient for the purpose of withdrawing body fluids. To accommodate the needs of the patient, a wide variety of types, sizes, and lengths of catheters are available to the physician. Catheters usually are individually sterilized and are packaged within a sealed, supporting structure for providing protection during shipping and handling.
The endotracheal tube is a type of catheter used by the anesthesiologist for intubation into the trachea of the patient in preparation for anesthesia. Endotracheal tubes may be smooth and uncuffed, or they may be of the cuff type, and a large variety of types, sizes and lengths are available to accommodate the needs of patients. The accepted medical procedure has been to package each endotracheal tube within its own individual sterilized pouch or container.
Standard connectors are generally inserted into the open proximal end of endotracheal tubes for ease of coupling the endotracheal tube to the anesthesia equipment. Such a connector frequently is packaged along with its mating endotracheal tube. Connectors also vary widely in sizes and types, and are available separately in sterilized containers.
The selection by the physician of a suitable catheter or endotracheal tube will be dependent upon the nature of the operation to be performed, the age and physical size of the patient, and the portion of the body to be intubated. Having selected a suitable catheter or endotracheal tube, as the nature of the operation may require, the physician must decide whether some form of guide or holder would help in intubating the catheter or endotracheal tube. A number of guides or aids are available to the physician for providing stiffening, guidance or mechanical rigidity to the flexible catheter or endotracheal tube. Such guides or aids are available in a number of sizes and lengths and generally are individually packaged and sterilized in their own containers. One example of a guide provided with an adjustable stop and handle is disclosed in U.S. Pat. No. 3,957,055.
Where a guide with adjustable stop is to be used with the selected catheter, it is necessary for the physician to assemble the appliance in preparation for intubation. This assembly calls for the steps of breaking the seal of the container supporting the guide, withdrawing the sterilized guide, determining the depth of penetration of the guide into the catheter, adjusting the position of the stop upon the guide, locking the position of the stop upon the guide, breaking the seal of the pouch to the catheter, inserting the distal end of the guide into the hollow, flexible catheter, and withdrawing the assembled appliance from the pouch. A similar procedure is followed for endotracheal tubes, and each of the steps in the procedure must be carried out without compromising the sterility of the appliance.
While the above-described procedure allows the maximum degree of flexibility to the physician in selecting a catheter, endotracheal tube, connector and guide from among the various types, sizes and lengths, it is not without its problems and shortcomings. The procedure is tedious, time-consuming and costly. Not only is there a risk of loss of sterility in assembling the appliance, there also may be a serious loss of time in attempting to locate the needed elements in emergency situations where time is crucial. This is especially true in accident cases where the patient must be intubated promptly with the correct endotracheal tube in preparation for anesthesia. The present invention overcomes the above problems and provides substantial improvements in packaged medical appliances.
A principal object of the present invention is to provide an assembled medical appliance sealed within a sterile envelope and ready for immediate use.
Another important object is to provide an assembled catheter with guide and stop sealed within a sterilized, flexible envelope and which may be manually configured into a desired shape without rupture of the envelope and without loss of sterility.
Another object of the invention is to reduce the cost of medical appliances which must be discarded after a single use.